SAFC Live – Blog on Biotech, Biopharma and Life Sciences

Archive for the ‘CMO’ Category

SAFC Lives presents personnel profiles where we talk to the people and personalities who make SAFC tick to find out more about their position, what drives them and what they enjoy doing when they’re not playing a critical role in the ongoing growth of SAFC.

In this edition, we talk with Kevin Kolell, Ph.D., Global Head of Technical Sales, based in Lenexa, KS. (more…)

SAFC is proud to sponsor the upcoming 2014 World ADC Summit in Frankfurt, Germany, February 17-20. Held at the Maritim Kurhaushotel Bad Homburg, the annual ADC Summit brings together leaders in the research and development of next-generation medicine and targeted therapeutics from across the globe.

In addition to sponsoring the event, SAFC will also be leading a discussion on Antibody Drug Conjugates (ADCs). Dr. Cynthia Wooge, Global Strategic Marketing at SAFC, will address “How to ensure success in technology transfer for ADCs while avoiding pitfalls,” at 9:00 a.m. on Wednesday, February 19. Her presentation will feature information about successful transfer to ensure robust and reproducible conjugation processes. Additionally, Cynthia will highlight the use of solid analytics to aid in the understanding of process controls and product characterization, appropriate engineering design, and the importance of effective communication.

SAFC and BioReliance are gearing up to attend the Informa Life Sciences Cell Line Development and Engineering Conference in Vienna, Austria, from February 10th to 14th. As industry leaders come together to share and discuss the newest technological trends in cell line development and engineering, SAFC and BioReliance will be onsite to contribute to these discussions.

Dr. Alison Armstrong, Senior Director of Development Services at BioReliance, will analyze industry standards in biosafety, identification and characterization assessment of cell banks. Her talk titled, “Cell Banking and Characterization: Regulatory Considerations” on Monday, February 10th at 12:40 p.m. will focus on new technologies and the fundamental aspects of cell banking and cell line characterization.

BioReliance and SAFC will close out the month of January in Washington, DC with attendance at two industry events.

First, the team will attend the Phacilitate Cell and Gene Therapy Forum from January 27 – 29, at the Grand Hyatt where influencers in the cell therapy, gene therapy and tissue engineered product sector will come together. SAFC will be onsite at Booth 48 to highlight the Carlsbad manufacturing capabilities and BioReliance testing services for gene therapies and viral vaccines.

Dave Backer, Senior Director & General Manager at SAFC, will participate in a panel discussion on cancer vaccines at 3:40 pm on Monday, January 27. The panel will focus on “Learning from past successes and failures to deliver game-changing efficacy.”

Backerwill also participate in the Immunotherapy forum within the session “Will stunning clinical results translate to commercial success for the next wave of Immunotherapy products?” on Tuesday, January 28 at 10:25 am.

BioReliance will also attend the CASSS – WCBP Symposium on the interface of regulatory analytical sciences for biotechnology health projects from January 28 – 30, at the Mayflower Hotel.

The team at CASSS will highlight BioReliance’s bioanalytical capabilities at Table 26.

SAFC’s cell line engineering team is continually working on enhancements to the proprietary CHOZN® Platform. Our latest enhancements target identifying genes that eliminate the possibility of immunogenic variants, and knocking out potentially problematic CMAH and GGTA1 gene sequences.

Growing interest in immunogenicity within the biopharmaceutical industry has continued to drive SAFC’s R&D into the existing CHOZN Platform, with the ultimate goal of creating a “Super CHO” expression system consisting of cell lines, vectors, media, and feeds that provide maximum output of biotherapeutic proteins with higher titers, better growth, and increased cell longevity.

In an interview with Cynthia Challener of Pharmaceutical Technology, Kevin Kayser, Senior Director, Head of R&D, talks about what sets the CHOZN Platform apart, predicts increased demand for these types of cell lines, and provides an insight into what the team is working on for the future.

It has been a bit quieter here at SAFC Live in the month of December as everyone prepares for time off during the holiday season. We can hardly believe that 2013 is almost over and wanted to take a moment to say THANK YOU for your support in 2013.

The teams at Sigma-Aldrich, SAFC and BioReliance strive to show our thanks to the communities we operate in through the year. In 2013, the team at BioReliance implemented various projects for charity and provided a great example of how giving back is not only rewarding, but also fun.

Employees volunteered time to various programs, participated in charity runs and walks, coordinated lab tours for local students and provided monetary support to local charities like the Joshua Frase Foundation (supporting myotubular myopathy treatment research). As the holidays approached, the team turned their attention to making the holidays brighter for local families with over 500 toys donated to the local chapter of Toys for Tots, and 2,186 pounds of food donations to Manna Food Center (www.mannafood.org) as part of the Sigma Aldrich global food drive. The success of the toy drive is driven by departmental toy exchanges where Secret Santas buy toys for co-workers instead of the traditional coffee mug.

We are sincerely appreciative of the communities we work in, our exceptional employees and valued partners – none of this is possible without you – and so we leave 2013 with our deepest thanks.

Best wishes for the happiest (and healthiest) of holidays and a prosperous new year. We look forward to seeing you on SAFC Live in 2014!

Just over a month ago, SAFC was onsite in Germany with 34,000 pharma professionals from across the globe for the annual CPhI Worldwide event. Leading into the event and during time onsite, contract manufacturing was on everyone’s minds as the changes in the pharmaceutical market continue to transform the traditional definitions for growth, competition and success in this sector.

For contract manufacturers looking to stay competitive and increase market share, the evolution of the industry can mean a myriad of things. SAFC’s own Global Head of Strategic Marketing, Dr. Andreas Weiler took part in multiple conversations about the status of the pharmaceutical industry, what he projects for the future and how SAFC is operating its own custom manufacturing services and solutions division in the changing market.